The ethics of pandemic getting more vaccine and using it wisely

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1 The ethics of pandemic getting more vaccine and using it wisely The Center for Vaccine Ethics and Policy a program of the Center for Bioethics, University of Pennsylvania, The Wistar Institute and Children s Hospital of Philadelphia

2 Facts about flu Influenza kills 30 50,000 people in the United States every year. Most of these are small children, the elderly, and people with chronic diseases Swine flu has killed more than 4300 people in America this year (to date) Flu vaccine prevents influenza in 70 90% of vaccinated healthy adults of working age Rates of flu in patients fall in direct proportion to vaccination rates of HCWs in institutional settings such as hospitals and nursing homes

3 Facts about flu So, bottom line, Flu is deadly, especially among the most vulnerable patients. Vaccine is effective and safe Thanks to The Pennsylvania Chapter of the American College of Physicians

4 Shortage of H1N1 vaccine Inadequate supply due to slow technology, poor yields of virus and contracts that lockdown supply to wealthy nations a small number of industrialized countries limiting vaccine availability for the rest of the world and especially in developing countries SAGE/WHO 7/7/9

5 Shortage of H1N1 vaccine 50 million doses set aside for poor nations but little vaccine has yet reached these countries and doubtful that it will anytime soon So public health ministries in countries which do not have A(H1N1) pandemic vaccines available face a daunting challenge: how to secure quickly safe, effective pandemic vaccine for their populations?

6 Shortage of H1N1 vaccine 40 organizations are either developing or already producing seasonal influenza vaccine, with most developing A(H1N1) vaccines as well. Many of these are small in scale and capacity, some are newer startups, some are located in developing countries Countries were encouraged to give attention to emergency provisions for use of unlicensed vaccines when considering potential vaccine use in their influenza preparedness plans SAGE/WHO 7/9/09

7 Shortage of H1N1 vaccine Many nations are shopping for vaccine. Some use brokers some direct government contacts to these companies there are no guidelines for governments, manufacturers, public health officials, patient advocacy groups to consider when a public health threat might justify making unlicensed and untested vaccines available to large numbers of persons

8 Ethics for emergency use there must be a determination by national and international bodies that a pandemic or public health threat exists that has the potential to cause severe adverse consequences existing methods for responding to the pandemic or public health threat are seen by experts as not sufficient for responding to the crisis

9 Ethics for Emergency Use data must exist from reliable animal studies showing trustworthy evidence of safety and efficacy of any vaccine proposed for emergency use clinical trials sufficient to demonstrate the safety of any vaccine proposed for emergency use should be undertaken manufacturers should give nations a reasonable opportunity to make their needs known

10 Ethics for Emergency Use Nations should have a plan in place for distributing vaccine in a fair, efficacious and transparent manner informed consent processes must be particularly robust and voluntary choice should be respected There must be a plan for handling any adverse events that appear to result from exposure to vaccination with a plan for compensation/care

11 HCWs and flu Influenza is highly contagious for 24 hours before symptoms begin many people, including unvaccinated healthcare workers are unwitting carriers

12 HCWs and flu Health care workers work sick Health care workers do not know when they are infectious Health care workers are expected to show up for work even if they are sick Health care workers often do not get many sick days Masks do not work well

13 HCW duties Protect the vulnerable, weak and defenseless Put patient interests first! Do no harm!!!

14 Duty to Protect Flu preys upon Babies Young children The elderly Immune compromised They merit protection

15 Patients First Every Code of Ethics AMA, ACP, ANA, SCCM, calls for putting patient interests ahead of professional self interest HCWs are professionals who put aside fears and doubts to help others akin to police, soldiers, fire dept members, EMTs Lessons of HIV, Katrina, World Trade Center

16 Do No Harm Infecting the weak and the vulnerable is to do the worst sort of harm Being unavailable to work in pandemics is to do harm Feeding vaccine fears and anti vaccine sentiments is to do grave harm Drinking Chinese teas, immune boosting vitamins, bathing with eucalyptus leaves Vaccines are a key weapon in patient safety and cutting hospital based deaths

17 Many people face vaccine mandates Military Oil workers Astronauts School children Biological and weapons labs Immigrants

18 Duty to be vaccinated There is a clear obligation/duty to be vaccinated on the part of physicians and other HCWs Leadership of nursing, medicine and pharmacy should be insisting on making flu and swine flu vaccination a condition of employment for those with clinical duties Health care institutions should be vaccine mandated zones for those who work there and have patient contact Every patient and long term care resident has a right to request care from vaccinated HCWs for their own safety

19 The Center for Vaccine Ethics and Policy a program of the Center for Bioethics, University of Pennsylvania, The Wistar Institute and Children s Hospital of Philadelphia